Status:
COMPLETED
Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Tanabe Pharma Corporation
Conditions:
Bronchial Asthma
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with asthma. Roflumilast will be administered orally once daily. The study duration consists o...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- Adult patients with bronchial asthma meeting the Guideline for Prevention and Control of Asthma 2003 (JGL 1998, revised 2nd edition)
- No change in asthma treatment during the last 4 weeks prior to the registration
- Non-smokers or ex-smokers for 12 months or more
- %FEV1 ranging between 60 and 80%
- Main exclusion criteria:
- Patients with poorly controlled asthma
- Inhalation therapy exceeding low dose during 4 weeks prior to the registration
- Concurrent respiratory diseases such as COPD considered to affect the efficacy evaluation
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00242307
Start Date
May 1 2004
End Date
June 1 2007
Last Update
November 2 2016
Active Locations (1)
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1
Nycomed Japan and Mitsubishi Tanabe Pharma Corporation
Osaka, Japan